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FDA Grants Fast-Track Designation for Genta's G3139 in Combination Therapy For Malignant Melanoma
LEXINGTON, Mass., Oct. 28 /PRNewswire/ -- Genta Incorporated (Nasdaq: GNTA - news) announced that the U.S. Food and Drug Administration (FDA) granted fast-track designation to the Company's bcl-2 antisense compound, G-3139, for use in combination with dacarbazine (DTIC) for treatment of advanced malignant melanoma. FDA's fast-track designation is intended to expedite review of new drug applications for products that have the potential to address unmet medical needs for serious, life-threatening diseases. Treatment of advanced malignant melanoma is one of several potential cancer indications for G3139 in clinical trials in the U.S., Canada and Europe.
On September 30, 1999 at the Cold Spring Harbor Conference on Programmed Cell Death, Dr. Burkhard Jansen, Principal Investigator at the University of Vienna, presented an update of clinical data from a Phase 1-2a study of G3139 plus dacarbazine for patients with malignant melanoma. In the patients who have been followed over six months, Dr. Jansen reported that the survival is predicted to exceed that observed in other recent studies using dacarbazine alone since several patients on treatment continue to survive with stable or responsive disease and the median survival has not yet been reached. Prolonged antitumor activity, lasting over one year in some cases, was observed in patients who were treated second-line after relapse from other first-line therapies. In addition to results using G3139 by intravenous infusion, Dr. Jansen reported favorable safety, pharmacology, and clinical response data of patients treated with dacarbazine plus G3139 given by twice-daily, subcutaneous injections. In view of these results, Dr. Jansen and his colleagues recommended that a G3139 and dacarbazine combination regimen should proceed rapidly to a Phase 3 trial.
``Fast-track designation will help accelerate our planned clinical development for G3139,' said Kenneth Kasses, Ph.D., President and CEO of Genta. 'This FDA designation underscores the importance of developing advances for malignant melanoma and will expedite the agency's review of 9 new drug applications for G3139. We believe that the FDA's designation of G3139 as a fast-track product for use in combination with DTIC in malignant melanoma also recognizes the potential for an advance in the treatment of this disease. In addition, we are encouraged by the clinical results reported thus far from Dr. Jansen's melanoma study and from a completed Phase 1-2 study in patients with non-Hodgkin's lymphoma, and we will continue to pursue additional clinical studies with G3139 in other cancers, including leukemia, small cell lung, colorectal, prostate, kidney and breast. The clinical data available from over 100 patients enrolled in the ongoing or completed Phase 1-2 studies indicate that G3139 is attractive for expanded clinical development in terms of safety, flexibility, and ease of use in the outpatient setting.``
Seven clinical trials are currently ongoing using G3139 by intravenous or subcutaneous route in patients with lymphoma and solid tumors, and additional clinical development is ongoing through a collaboration with the National Cancer Institute to study G3139 for patients with small cell lung cancer, colorectal cancer and acute leukemia.
G3139 was designed to reduce the Bcl-2 protein level in cancer through an ``antisense' mechanism that specifically targets the messenger-RNA produced by the bcl-2 gene. In many human cancers, the Bcl-2 protein is believed to be a major factor in inhibiting apoptosis, or programmed cell death, and in contributing to resistance of those cancers to treatment with anticancer drugs.
Genta Incorporated (Nasdaq: GNTA - news) is a biopharmaceutical company whose strategy consists of building a product and technology portfolio concentrating on cancer therapy including its Anticode(TM) (antisense) products intended to treat cancer at its genetic source. For more detailed information about Genta, please visit our website at www.Genta.com .
To receive Genta Incorporated's latest news release and other corporate documents via fax, at no cost, dial 1-800-PRO-INFO; use the Company's symbol GNTA. Or visit The Financial Relations Board's web site at www.frbinc.com.
The statements contained in this press release that are not historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the expectations, beliefs, intentions or strategies regarding the future. Without limiting the foregoing, the words ``anticipates,' ``believes,' ``expects,' ``intends,' ``may' and ``plans' and similar expressions are intended to identify forward-looking statements. The Company intends that all forward-looking statements be subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect the Company's views as of the date they are made with respect to future events, but are subject to many risks and uncertainties, which could cause the actual results of the Company to differ materially from any future results expressed or implied by such forward-looking statements. For example, the results obtained in pre-clinical or clinical studies reported above may not be indicative of results that will be obtained in future clinical trials; Genta has not successfully completed human clinical trials of a product based on antisense technology; and delays in the completion of clinical trials as a result of delays in patient enrollment or other factors may occur. Examples of such risks and uncertainties also include, but are not limited to: the obtaining of sufficient financing to maintain the Company's planned operations; the timely development, receipt of necessary regulatory approvals and acceptance of new products; the successful application of the Company's technology to produce new products; the obtaining of proprietary protection for any such technology and products; the impact of competitive products and pricing and reimbursement policies; and the changing of market conditions. The Company does not undertake to update forward-looking statements. |
